510(k) K262211
K262211 is an FDA 510(k) premarket notification submitted by Tianjin Huahong Technology Co., Ltd. for the device "Lancet". The FDA issued a decision of Substantially Equivalent on Jul 22, 2026. The device falls under product code QRL (Multiple Use Blood Lancet For Single Patient Use Only), a Class II device regulated under 21 CFR 878.4850. Tianjin Huahong Technology Co., Ltd. has 15 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 22, 2026
- Date Received
- Jun 30, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Multiple Use Blood Lancet For Single Patient Use Only
- Device Class
- Class II
- Regulation Number
- 878.4850
- Review Panel
- SU
- Submission Type
- 510(k)
A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.